Dilaudid Subs for Heroin in Supervised Injection Program

— Hydromorphone proved non-inferior to diacetyl morphine

by Kristina Fiore,Associate Editor, MedPage Today
April 8, 2016

MedpageToday

Hydromorphone (Dilaudid) may be able to substitute for heroin in medically supervised injection programs, researchers found.

In a single-center randomized study, maintenance hydromorphone didn't meet non-inferiority to maintenance diacetylmorphine (heroin) for days of self-reported street heroin use in the intention-to-treat (ITT) analysis, but it did so in the per-protocol (PP) analysis, according to Eugenia Oviedo-Joekes, PhD, of the University of British Columbia in Vancouver, and colleagues.

Action Points

Hydromorphone (Dilaudid) may be able to substitute for heroin in medically supervised injection programs.

Note that in the U.S., medically supervised heroin isn't legal, so using a potent opioid that is approved for other uses, like hydromorphone, could be an alternative.

It also proved non-inferior in both types of analyses for two other co-primary endpoints, namely self-reported use of any opioid and positive urine screens, they reported online in JAMA Psychiatry.

"The results of our study suggest that hydromorphone is as effective as diacetylmorphine for this subgroup of individuals with severe opioid use disorder," they wrote.

Medically supervised maintenance therapy with heroin has been shown in previous trials to be a good option for those who haven't been able to beat addiction with other medication assisted therapy (MAT) such as methadone or buprenorphine.

There are medically supervised heroin injection programs in Germany, the Netherlands, Switzerland, and Denmark, where this type of therapy accounts for 5% to 8% of all those enrolled in substitution programs.

But in some countries, including the U.S., medically supervised heroin isn't legal, so using a potent opioid that is approved for other uses, like hydromorphone, could be an alternative.

To test whether it would be equivalent to heroin for this use, Oviedo-Joekes and colleagues enrolled 202 patients in a 6-month study at a single site in Vancouver. The participants had previously tried to treat their addiction but were unsuccessful. More than half (60%) of them were homeless.

The primary outcome was self-reported days of street heroin use in the prior month, with co-primary endpoints of self-reported days of any street-acquired opioids in the last month, and urine screens positive for street heroin markers.

Overall, the authors saw good compliance. Patients came, on average, twice a day every day of the week for their injections, and so were also able to get medical and psychosocial support.

There was also good masking in the trial, with about 50% of those in the hydromorphone group thinking they were getting heroin, or were unsure of what they were getting. About 65% of those in the heroin group thought they were getting hydromorphone or were unsure, "indicating successful masking," the researchers wrote.

Although hydromorphone didn't meet noninferiority criteria for the primary outcome of self-reported days of street heroin use in the ITT analysis, it did so in the PP analysis, Oviedo-Joekes and colleagues reported.

And it proved non-inferior on the two other co-primary endpoints of self-reported days of any street opioid use and positive urine screens in both the ITT and PP analyses, they found.

There were 29 serious adverse events, with the majority (24) occurring in the hydromorphone group. Seizures and overdoses accounted for the majority of serious adverse events, but there were two deaths, both of which were in the heroin group.

In an accompanying editorial, Richard Schottenfeld, MD, and Stephanie O'Malley, PhD, of Yale University in New Haven, Conn., said the accumulating evidence is starting to reveal the "critical public health importance of expanding access and reducing barriers to evidence-based, medication-assisted treatments for opioid use disorder, and improving treatment retention and treatment effectiveness for patients who do not benefit optimally from existing treatments."

They warned that it's not just heroin therapy that's outlawed in the U.S. "With the exception of methadone and buprenorphine, many countries (including the U.S.) prohibit the use of other opioids for the treatment of opioid use disorder, and regulatory changes would be required to permit supervised hydromorphone injection."

"Nonetheless," they concluded, "one of the great values of this study is its focus on developing and evaluating treatments for some of the most difficult-to-reach and difficult-to-treat persons who inject heroin."

Last Updated April 11, 2016

The study was supported by the Canadian Institutes of Health.

Oviedo-Joekes and co-authors disclosed no relevant relationships with industry.

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